In September 2019, the Food & Drug Administration (FDA) issued a warning letter to JUUL Labs. The FDA warning letter ordered JUUL to stop marketing its product as safer than cigarettes. The FDA cited testimony that JUUL had been marketing its vaping products as “modified risk tobacco products.” That means, the company claimed its product presented a lower risk of tobacco-related disease or was less harmful than traditional tobacco products. Here’s the real catch — JUUL actually presented at school programs. The Congressional testimony contained evidence of a JUUL representative actually speaking at a school and telling students their product “was much safer than cigarettes.” You can read more about the FDA letter in a Washington Post article titled FDA Blasts JUUL For Illegally Marketing E-Cigarettes As Less Harmful Than Regular Cigarettes.
We have been investigating claims related to defective 3M earplugs used by members of our armed forces. Why are these defective earplugs an important issue? To answer that question, we need to examine first the impact of hearing loss and tinnitus on our veterans. I thought hearing loss and tinnitus among veterans may be a good topic for this post.
Veterans Suffer Significant Hearing Loss And Tinnitus Problems
Are hearing problems a major issue for veterans? Here is what the U.S. Department of Veterans Affairs says about the issue:
A new research article asks if physicians are starting to move patients away from Invokana use? It’s a good question. On this blog, I’ve written about Invokana numerous times. For a detailed history of the drug, you can read some of my past articles which are cited at the end of this post.
What is Invokana? The drug is in a class of medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other drugs in this class include Farxiga, Jardiance, Glyxambi, and Xigduo XR. SGLT2 inhibitors work by altering kidney function to stop reabsorption of glucose into the blood stream.
Diabetes is a huge health problem in the United States. Here, in Alabama, we suffer one of the highest rates of diabetes. Diabetic patients need good medical care. What they do not need are pills that carry more risk than benefit. While we need medications, we need those medications to be tested and safe for use. That’s why the growing list of serious injuries associated with Invokana is an important issue to Alabama patients (and a frequent topic of this blog).
A recent study estimated a significant percentage of medical studies are ghostwritten. The really troubling detail — Up to half of all medical studies may be ghostwritten by companies with a financial interest in the research.
Next time you see or read a medical article listing a researcher or physician as the author, take a step back. Did the listed author really write the article? Maybe. Maybe not. Maybe a drug company or medical device company funded and really authored the article.
Consider the revealing article published by former ghostwriter Linda Logdberg. The article is titled Being the Ghost in the Machine: A Medical Ghostwriter’s Personal View. How does Ms. Logdberg now feel about her former career?
Recent research shows a dangerous problem with many newly approved drugs. Life-threatening side effects are common in the years following FDA approval. An article titled “Study: Side effects emerge after approval for many US drugs” details the new research. The article’s opening paragraph sums it up:
Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications . . .
This new study followed all prescription drugs approved by the Food and Drug Administration (FDA) from 2001 through 2010. The drugs flagged because of serious post-approval problems included medications for common medical problems such as arthritis, infections, blood clots and depression. The study’s lead author (an associate professor at Yale University) said “the large percentage of problems was a surprise.” As for me — I’m not surprised.
On May 16, the Food and Drug Administration (FDA) issued a new warning about the diabetes drug Invokana. Now, the FDA “has concluded” based on tests that the drug presents an increased risk of foot and leg amputations. Specifically, the FDA safety alert says:
Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Did Johnson & Johnson fail to warn women of ovarian cancer risks related to the use of its talcum powder products? For years, Johnson & Johnson has marketed its talcum powder products for feminine hygiene. Yet, the company never warned that the use of talcum powder for feminine hygiene may be linked to ovarian cancer.
Since the early 1970s, numerous studies have indicated an increase in the risk of ovarian cancer with this use of talcum powder. So, why did Johnson & Johnson not warn consumers? Why did Johnson & Johnson continue to make money marketing these products as safe and effective for women? These are questions being raised by women who have suffered ovarian cancer after years of using talcum powder products.
For detailed information, take a look at our page on Talcum Powder Lawsuits located under the Hot Topics section of our firm website. We provide information about talcum powder and the history of its use by Johnson & Johnson. We are happy to answer additional questions as well.
The nation’s leading business group is mounting a new attack on advertisements run by trial lawyers that tell consumers about the negative side effects from medical drugs and devices.
Let me start — I don’t like modern attorney advertising. Locally in northern Alabama, we have an attorney on television advertising for automobile accident injury cases who refuses to help injured people in court. Think about that — The lawyer asks for your injury case but won’t go to court when needed! Another Huntsville law firm raised billboards seeking personal injury cases but then added fine print to their website saying they really intend to sign and refer the cases to outside counsel. These lawyers serve themselves, not their clients. When it comes to drugs and medical devices, we even have lawyers running ads who are not licensed in Alabama.
I find most of these ads distasteful. Complaints about them are completely justified. Yet, the Chamber of Commerce’s approach is pure hypocrisy. While attacking television advertisements from lawyers, the Chamber has done nothing to reduce deceptive drug company advertisements. The Chamber is protecting the drug companies who rush deadly and dangerous drugs to market for huge profits. As one attorney noted:
Our office has closely followed developments related to the diabetes drug Invokana. For more details on the medication and how it works, you can read a report under the Hot Topics section of our firm website. As we discuss on our website, Invokana is a relatively new diabetes drug manufactured by Johnson & Johnson. Yet, in just a few years on the market, the FDA has issued numerous safety communications about the drug.
- Diabetic ketoacidosis.
- Kidney damage.
We are currently investigating claims of permanent hair loss following the use of Taxotere, a chemotherapy drug. Taxotere is one of the most widely used drugs for breast cancer in the United States. For more information on the drug, you can read a detailed report on the Blackwell Law Firm website.
While cancer patients may expect temporary hair loss during chemotherapy treatment, they also expect their hair to regrow once treatment ends. For many patients, hair regrowth is a visible sign of victory over the disease. And, if hair regrowth does not occur, the physical and emotional impacts can be devastating.
Although expected to be temporary, many patients treated by Taxotere suffer permanent hair loss. These women had alternatives to Taxotere treatment. Other drugs provide similar success results. Yet, those other drugs do not leave many patients with permanent alopecia or baldness. For years, Taxotere’s manufacturer failed to warn doctors or patients in the United States of this harm. Patients had no knowledge of the risk and could not make an informed choice between available drugs. Although the manufacturer failed to warn patients, it knew the significant risk of injury. And, it continued to profit from sales to unsuspecting patients.